Concordance of Inivata Liquid Biopsy With Standard of Care Tissue Testing
The aim of this study is to evaluate the performance of Inivata liquid biopsy analysis compared with standard tissue biopsy analysis for detection of genomic alterations in patients with advanced lung cancer.
Ask AI to explain this studyKey things to know
This describes the study’s primary purpose.
The study team can explain what participation involves.
These are broad labels—not an eligibility decision.
Checked against the public recordLast updated May 16, 2019 · Source: ClinicalTrials.gov
Ask the study team to confirm whether enrollment is open.
Observational
Locations may change over time.
Study sponsor
What this study is about
- Purpose
- Not specified
- Study type
- Observational
- Phase
- Not applicable
- Sponsor
- Inivata
- Interventions being studied
- Not specified
How this study is categorized
These labels come from structured fields and exact terms in the public record.
Who may be able to participate
The sponsor separates these requirements into two groups. You do not need to interpret them alone—use them to guide a conversation with the study team.
- Written, signed and dated informed consent to participate in the study must be given by the patient in accordance with 21 CFR Part 312, the International Conference on Harmonisation (ICH) Good Clinical Practice (GCP) Guideline E6, and applicable regulations, before completing any study-related procedures.
- Male and female patients aged 18 years and over diagnosed with stage IIIb/IV non-squamous NSCLC.
- Arms A and B: Patients intended to initiate first-line treatment according to standard guidelines. Note, a patient is eligible to receive sterotactic radiosurgery (no whole-brain radiotherapy). Arm C: Patients who are at a second-line treatment setting or greater may participate. Note, a patient may be included if they have metastatic brain lesions. Arms A, B, C: If enrolled in a treatment clinical trial, patients may also enroll in this study if all eligibility criteria are met.
- Arm A only: Patients intended to initiate first-line treatment according to standard guidelines who plan to have or have had a recent tumor tissue biopsy taken for molecular profiling as part of their standard of care.
- Patient must understand and be able, willing and likely to fully comply with all study procedures and restrictions.
- Patients who have received any approved or experimental cancer therapy since their most recent NSCLC tissue biopsy (Arms A and B)
- Patients who have any other prior metastatic or current second primary cancer (Arms A and B)
- Patient who has a severe acute or chronic medical or psychiatric condition or laboratory abnormality that may increase the risk associated with study participation or may interfere with the interpretation of study results and, in the judgment of the Investigator, would make the patient inappropriate for entry into this study.
Important: This is the sponsor’s public criteria, not a determination of eligibility. The study team must review your individual situation.
U.S. locations
- Facey Medical FoundationMission Hills, California
- University of Colorado Cancer CenterAurora, Colorado
- Eastern CT Hematology OncologyNorwich, Connecticut
- Christiana Care Health Services IncNewark, Delaware
- Holy Cross HospitalFort Lauderdale, Florida
- Mid-Florida Hematology and Oncology CentersOrange City, Florida
- Swedish Covenant HospitalChicago, Illinois
- Edward M Kaplan, MD & AssociatesSkokie, Illinois
- Cotton O'Neil Clinical Research CenterTopeka, Kansas
- Norton Healthcare IncLouisville, Kentucky
- Christus Cancer Treatment CenterShreveport, Louisiana
- Berkshire Hematology Oncology ServicesPittsfield, Massachusetts
Source and freshness
Processed from ClinicalTrials.gov. Last public update: May 16, 2019. Always confirm current availability with the study team.